Comparative Effectiveness of endoscopic assessment of GER and BE

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DESCRIPTION (provided by applicant): Barrett's esophagus (BE), a well-known complication of GER, is the strongest known precursor of esophageal adenocarcinoma (EAC). Thus, identifying effective screening approaches for the early detection of BE are highly desired. Current impediments to BE screening include 1) the inability to utilize sedated endoscopy (sEGD) effectively in populations and 2) current GER-based paradigms for detecting BE. Referral center studies demonstrate comparable accuracy between unsedated transnasal endoscopy (uTNE) and sEGD. However, patient acceptability and diagnostic yield with uTNE in general populations remain unknown. Preliminary Studies from our group have identified a significant level of interest for BE screening, and demonstrated initial feasibility of using uTNE and sEGD within a defined population. We propose to test the Central Hypothesis that the comparative effectiveness of uTNE will be greater than sEGD in population screening for BE with the following specific aims: Specific Aim 1: To assess participation in screening for BE with uTNE and sEGD in a population cohort. Subaim 1a: To compare participation rates for BE screening with uTNE and sEGD. We will randomly sample three age (> 50 years), gender and reflux symptom stratified cohorts (150 subjects each) from a defined population cohort. Each subject will be randomized to either sEGD (cohort 1), or uTNE in the hospital (huTNE, cohort 2), or uTNE within a mobile health care van (muTNE, cohort 3). Subaim 1b: To assess predictors of participation in population screening of BE. A priori demographic and clinical factors will be collected and analyzed to identify predictors of participation in screening. Specific Aim 2: To prospectively compare the clinical effectiveness of uTNE and sEGD in a population cohort. Subaim 2a: To compare the quality of esophageal assessment between sEGD, huTNE and muTNE cohorts. Quality criteria will include 1) successful esophageal intubation, 2) complete esophageal evaluation, 3) successful biopsy acquisition, 4) independent quality score by video evaluation using a validated scoring too. Subaim 2b: To compare the rates of detection of esophageal injury (esophagitis, strictures and BE) between cohorts stratified by presence/absence of GER symptoms using a validated symptom questionnaire. Specific Aim 3: To prospectively compare the short-term resource utilization and patient preferences for screening using sEGD, huTNE and muTNE in a population-based cohort. Subaim 3a: To measure the short term patient reported disutilities (patient preference associated with each test strategy) using a validated tool in the three test strategy cohorts. Subaim 3b: To compare the total short term costs (direct and indirect) and distribution of costs by type of service associated with each test strategy. The Significance that underlies the proposed research is based on the need to identify effective community- based screening strategies for BE which has the potential of improving outcomes of patients with EAC. PUBLIC HEALTH RELEVANCE: Barrett's esophagus is a precursor and strong risk factor for esophageal adenocarcinoma: a cancer with rapidly rising incidence in the United States. In this proposal we aim to identify the most acceptable and accurate way to detect Barrett's esophagus in the community by comparing regular endoscopy (performed with sedation) to unsedated transnasal endoscopy (using a thin endoscope inserted through the nose) in the community.